Featured Articles
INTRAORAL DELIVERY - Utilization of Intraoral Administration for Enablement & Enhancement of Drug Delivery – Highlights of Recent Commercial Products
Zhen Yang, PhD, and Yunhui Wu, PhD, highlight several commercialized intraoral formulations from a clinical pharmacokinetic perspective and reveal its mechanism for enablement or enhancement of drug delivery via intraoral administration.
BUCCAL DELIVERY - Dissolvable Film Format Evolves to Buccal Drug Delivery Applications
Scott D. Barnhart indicates the buccal and sublingual oral mucosa will continue to be an area of growing interest for drug delivery as researchers evaluate ways to improve bioavailability, patient compliance, and product lifecycle beyond tablet and injectable formats.
ANTIBODY DRUG CONJUGATES - ADC Development Using SMARTag(TM) Technology
Robyn M. Barfield, PhD, and David Rabuka, PhD, say that despite challenges, there has been progress in advancing complex compounds through clinical trials and successfully treating patients, and these bioconjugate compounds include a subset of molecules known as ADCs.
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 2 – Analysis)
Tugrul T. Kararli, PhD, MBA, Kurt Sedo, and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.
DISPOSABLE TECHNOLOGY - Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations
Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?
EXECUTIVE INTERVIEW - Array BioPharma: Steadily Moving to Late-Stage Development, Preparing for Commercialization
Executive Summary: Ron Squarer, Chief Executive Officer of Array BioPharma, talks about the company’s pipeline and evolution into a fully integrated, commercial-stage biopharmaceutical company.
EXECUTIVE INTERVIEW - BioCellChallenge: Optimizing the Potential of Intracellular Therapeutic Antibodies
Drug Development Executive: Dr. Laurent Meunier, CEO of BioCellChallenge, discusses the development of a new liposomal formulation allowing the use of intracellular therapeutic antibodies.
BIOAVAILABILITY ENHANCEMENT - Diffusion of Innovation & the Adoption of Solubilization Technologies
Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.
BUSINESS DEVELOPMENT - Traffic Light Decision-Making
All of us have faced decisions in which, if we make the right decision, we are a hero, and if we make the wrong one,…
CELL THERAPIES - The Challenges & Possible Solutions for Transferring Cell Therapy From the Bench to the Industry
Lior Raviv, MMedSc, and Ohad Karnieli, PhD, discuss the significant emerging challenges in downstream processing of cell therapies focused mostly on allogeneic therapies.
ADVANCED DELIVERY DEVICES - New Drug Delivery & Stabilization Platforms Gaining Global Interest
Sam de Costa, PhD, believes the launch of two stabilization and drug delivery platforms that have the potential to revolutionize the delivery of vaccines, therapeutics, and diagnostics, while significantly cutting costs, has attracted sharp interest from pharmaceutical and biotech companies around the world.
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 1 – Introduction)
Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD; believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.
EXECUTIVE INTERVIEW - Hermes Pharma: User-Friendly Dosage Forms, a Win-Win Situation for Patients & Pharma
Drug Development Executive: Dr. Thomas Hein, Director, Sales & Business Development at Hermes Pharma, discusses how user-friendly dosage forms help put patients first, their advantages for patients and pharmaceutical companies, as well as the challenges associated with their development and production.
BIOAVAILABILITY ENHANCEMENT - Analysis of the Historical Use of Solubilization Technologies
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
SPECIAL FEATURE- Analytical Testing of Biologics & Biosimilars
Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.
BUSINESS DEVELOPMENT - The Compensation Paradox
John A. Bermingham is currently the COO of 1st Light Energy & Conservation Lighting. He was previously Co-President and COO of AgraTech, a biotech enterprise focused on chitosan, a biomaterial processed from crustacean shells (shrimp, crawfish, crab, etc), as well as President & CEO of Cord Crafts, LLC, a leading manufacturer and marketer of permanent botanicals. Prior to Cord Crafts, he was President & CEO of Alco Consumer Products, Inc., an importer of house ware, home goods, pet, and safety products under the Alco brand name and through licenses from the ASPCA and Red Cross. He successfully turned around the company in 60 days and sold Alco to a strategic buyer. Mr. Bermingham was previously the President & CEO of Lang Holdings, Inc. (an innovative leader in the social sentiment and home décor industries) and President, Chairman, and CEO of Ampad (a leading manufacturer and distributor of office products). With more than 20 years of turnaround experience, he also held the positions of Chairman, President, and CEO of Centis, Inc., Smith Corona Corporation, and Rolodex Corporation. He turned around several business units of AT&T Consumer Products Group and served as the EVP of the Electronics Group and President of the Magnetic Products Group, Sony Corporation of America. Mr. Bermingham served 3 years in the U.S. Army Signal Corps with responsibility for Top Secret Cryptographic Codes and Top Secret Nuclear Release Codes, earned his BA in Business Administration from Saint Leo University, and completed the Harvard University Graduate School of Business Advanced Management Program.
THERAPEUTIC FOCUS - Repurposing Drugs to Transform Lives
Roger Garceau, MD, FAAP, presents a drug that might have slipped into obscurity if the team at NPS Pharmaceuticals had accepted defeat, but instead, the medicine has received an extraordinary second chance to address a different, and significant, unmet medical need.
MARKET BRIEF - Latin America Next-Generation Biosimilars Market: Opportunities & Future Growth
Lucila Rocca, Healthcare Industry Analyst, Frost & Sullivan, indicates the Latin American Biosimilars market will grow at a significant rate in the next 5 years, and the importance of establishing rigorous regulation will stimulate this market growth.
MANAGEMENT INSIGHT - In Pursuit of Ethics: Reflections On Why We Do What We Do
In January, the FDA banned imports from a fourth Ranbaxy plant in India after an unscheduled inspection revealed a lab littered with flies, a leaking…
RESIDUAL IMPURITIES - Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment
Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.
